155 pipeline articles
Xatmep receives FDA approval for pediatric acute lymphoblastic leukemia and polyarticular juvenile idiopathic arthritis
FDA approves Xatmep for pediatric leukemia and arthritis treatment options
The FDA has approved Xatmep for pediatric patients with acute lymphoblastic leukemia or active polyarticular juvenile idiopathic arthritis. …
The FDA has approved Xatmep to treat specific forms of childhood leukemia and arthritis, offering new options for young patients.
FDA Approves Nulibry (cyclic pyranopterin monophosphate) for Molybdenum Cofactor Deficiency Type A
FDA approves first drug for rare genetic disorder MoCD Type A.
FDA approved Nulibry (cyclic pyranopterin monophosphate) to reduce mortality risk in patients with molybdenum cofactor deficiency (MoCD) Typ…
The FDA approved Nulibry to reduce the risk of death in patients with molybdenum cofactor deficiency (MoCD) Type A, a rare genetic disorder …
FDA Approves Jylamvo (methotrexate) for Multiple Neoplastic and Inflammatory Indications
FDA approves Jylamvo, a liquid methotrexate for cancer and arthritis.
The FDA approved Jylamvo (methotrexate) oral solution for acute lymphoblastic leukemia, mycosis fungoides, non-Hodgkin lymphoma, rheumatoid …
The FDA approved Jylamvo (methotrexate) oral solution for several cancers and inflammatory conditions. It treats certain leukemias, lymphoma…
FDA Approves Hepcludex (bulevirtide) for Chronic Hepatitis Delta Virus Infection
FDA approves new drug Hepcludex for chronic hepatitis delta infection.
FDA approved Hepcludex (bulevirtide) for chronic HDV infection in adults without cirrhosis or with compensated cirrhosis. Approval was based…
The FDA approved Hepcludex (bulevirtide) for adults with chronic hepatitis delta virus (HDV) infection who have no or compensated cirrhosis.…
FDA Approves Argatroban in Sodium Chloride for Thrombosis in HIT and PCI
FDA approves new blood thinner for patients with rare clotting disorder.
The FDA approved Argatroban in Sodium Chloride injection for prophylaxis or treatment of thrombosis in adult patients with heparin-induced t…
The FDA approved Argatroban in Sodium Chloride injection to prevent or treat blood clots in adults with heparin-induced thrombocytopenia (HI…
FDA Approves Linzess (linaclotide) for IBS-C, CIC, and Pediatric Functional Constipation
FDA approves Linzess for irritable bowel syndrome and constipation in adults and children.
FDA approved Linzess (linaclotide) for irritable bowel syndrome with constipation in adults and pediatric patients 7 years and older, chroni…
The FDA approved Linzess (linaclotide) for irritable bowel syndrome with constipation in adults and children ages 7 and older, and for chron…
FDA Approves Datroway (datroway) for EGFR-Mutated NSCLC and HR+ Breast Cancer
FDA approves new drug Datroway for two types of advanced cancer.
The FDA approved Datroway for two indications: locally advanced or metastatic EGFR-mutated NSCLC after prior EGFR-directed therapy and plati…
The FDA approved Datroway for two advanced cancers: a type of lung cancer with EGFR mutations and a type of breast cancer that is HR-positiv…
FDA Approves Tofidence (tocilizumab-bavi) for Multiple Inflammatory Conditions and COVID-19
FDA approves new biosimilar drug Tofidence for arthritis and COVID-19.
FDA approved Tofidence (tocilizumab-bavi), an IL-6 receptor antagonist, for rheumatoid arthritis, giant cell arteritis, polyarticular juveni…
The FDA approved Tofidence (tocilizumab-bavi), a biosimilar to tocilizumab, for rheumatoid arthritis, giant cell arteritis, juvenile arthrit…
FDA Approves Fintepla (fenfluramine) for Seizures in Dravet and Lennox-Gastaut Syndromes
FDA approves new drug Fintepla for two rare seizure disorders.
The FDA approved Fintepla (fenfluramine) for seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients aged 2 years a…
The FDA approved Fintepla (fenfluramine) to treat seizures in people aged 2 and older with Dravet syndrome or Lennox-Gastaut syndrome. This …
FDA Approves Children's Claritin (loratadine) for Allergic Rhinitis Symptoms
FDA approves Children's Claritin chewable tablets for allergy relief in kids 2 and older.
The FDA approved Children's Claritin (loratadine) chewable tablets for temporary relief of hay fever or upper respiratory allergy symptoms i…
The FDA approved Children's Claritin (loratadine) chewable tablets for hay fever and allergy symptoms in children ages 2 and older. It treat…
FDA Approves Xyzal Allergy 24hr (levocetirizine) for Hay Fever and Respiratory Allergy Symptoms
FDA approves new over-the-counter allergy drug Xyzal Allergy 24hr
The FDA approved Xyzal Allergy 24hr (levocetirizine) for temporary relief of symptoms due to hay fever or other respiratory allergies, inclu…
The FDA approved Xyzal Allergy 24hr (levocetirizine) for temporary relief of hay fever and other allergy symptoms like runny nose, sneezing,…
FDA Approves Venclexta (venetoclax) for CLL/SLL and AML
FDA approves new drug Venclexta for certain blood cancers
FDA approved Venclexta (venetoclax) for adult patients with CLL or SLL, and in combination with azacitidine, decitabine, or low-dose cytarab…
The FDA approved Venclexta (venetoclax) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is also a…
FDA Approves Cholbam (cholic acid) for Bile Acid Synthesis Disorders and Peroxisomal Disorders
FDA approves first treatment for rare bile acid disorders.
FDA approved Cholbam (cholic acid) for treatment of bile acid synthesis disorders due to single enzyme defects and as adjunctive treatment f…
The FDA approved Cholbam (cholic acid) for two rare inherited conditions that affect the liver and digestion. This is the first approved the…
FDA Approves Rinvoq Lq (upadacitinib) for Polyarticular Juvenile Idiopathic Arthritis
FDA approves new oral drug Rinvoq Lq for children with arthritis.
The FDA approved Rinvoq Lq (upadacitinib) for patients 2 years and older with active polyarticular juvenile idiopathic arthritis after inade…
The FDA approved Rinvoq Lq (upadacitinib) for children ages 2 and older with active polyarticular juvenile idiopathic arthritis (pJIA) who d…
FDA Approves Tyenne (tocilizumab-aazg) for Multiple Inflammatory Conditions
FDA approves new biosimilar drug Tyenne for arthritis and other conditions.
The FDA approved Tyenne (tocilizumab-aazg), an IL-6 receptor antagonist, for rheumatoid arthritis, giant cell arteritis, polyarticular and s…
The FDA approved Tyenne, a biosimilar to tocilizumab, for several inflammatory conditions including rheumatoid arthritis and giant cell arte…
FDA Approves Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) for HIV-1 Infection
FDA approves new once-daily pill Biktarvy for HIV treatment in adults and children.
The FDA approved Biktarvy, a three-drug combination of bictegravir, emtricitabine, and tenofovir alafenamide, for HIV-1 infection in adults …
The FDA approved Biktarvy, a once-daily pill for HIV-1 infection. It is for adults and children weighing at least 14 kg who are new to treat…
FDA Approves Tyenne (tocilizumab-aazg) for Multiple Indications Including RA and COVID-19
FDA approves new biosimilar drug Tyenne for arthritis and COVID-19
The FDA approved Tyenne (tocilizumab-aazg), a biosimilar to tocilizumab, for multiple indications including rheumatoid arthritis, giant cell…
The FDA has approved Tyenne, a biosimilar to tocilizumab, for several inflammatory conditions and COVID-19. It treats rheumatoid arthritis, …
FDA Approves Onapgo (apomorphine) for Motor Fluctuations in Advanced Parkinson's
FDA approves Onapgo for motor fluctuations in advanced Parkinson's disease.
FDA approved Onapgo (apomorphine hydrochloride) subcutaneous infusion for motor fluctuations in adults with advanced Parkinson's disease. Th…
The FDA approved Onapgo (apomorphine hydrochloride) for adults with advanced Parkinson's disease who have motor fluctuations. It is given as…
FDA Approves Baxfendy (baxfendy) for Hypertension in Adults Not Adequately Controlled
FDA approves new drug Baxfendy to help lower high blood pressure.
FDA approved Baxfendy, an aldosterone synthase inhibitor, for hypertension in adults not adequately controlled on other agents. It is used i…
The FDA approved Baxfendy (baxfendy) for adults with high blood pressure not controlled by other medicines. It is taken with other blood pre…
FDA Approves Herceptin (trastuzumab) for HER2-Overexpressing Breast and Gastric Cancers
FDA approves Herceptin for certain breast and stomach cancers.
The FDA approved Herceptin (trastuzumab) for the treatment of HER2-overexpressing breast cancer (adjuvant and metastatic) and HER2-overexpre…
The FDA approved Herceptin (trastuzumab) for HER2-positive breast cancer and stomach cancer. It targets tumors with high levels of HER2 prot…
FDA Approves Phesgo (pertuzumab, trastuzumab, hyaluronidase) for HER2-Positive Breast Cancer
FDA approves new shot for HER2 positive breast cancer treatment
The FDA approved Phesgo, a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase for subcutaneous injection, for HER2-positiv…
The FDA approved Phesgo, a new shot for HER2 positive breast cancer. It treats early and metastatic breast cancer. This gives patients a fas…
FDA Approves Herceptin Hylecta (trastuzumab/hyaluronidase) for HER2+ Breast Cancer
FDA approves new shot for HER2 positive breast cancer treatment
FDA approved Herceptin Hylecta, a subcutaneous formulation of trastuzumab with hyaluronidase, for adjuvant and metastatic HER2-overexpressin…
The FDA approved Herceptin Hylecta, a shot for HER2 positive breast cancer. It is given under the skin in minutes instead of an IV drip. Thi…
FDA Approves Mavenclad (cladribine) for Relapsing Forms of Multiple Sclerosis
FDA approves new multiple sclerosis drug Mavenclad for relapsing forms
The FDA approved Mavenclad (cladribine) for relapsing forms of MS, including relapsing-remitting and active secondary progressive disease, i…
The FDA approved Mavenclad (cladribine) for adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting and active…
FDA Approves Argatroban for Thrombosis in Heparin-Induced Thrombocytopenia
FDA approves Argatroban to treat blood clots in patients with HIT
The FDA approved argatroban for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) and as …
The FDA approved Argatroban to prevent or treat blood clots in adults with heparin-induced thrombocytopenia (HIT), a condition where heparin…
FDA approves nuzyra for community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections in adults
FDA approves nuzyra for treating bacterial infections in adult patients safely
The FDA granted approval for nuzyra to treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections i…
The FDA has approved nuzyra to treat community-acquired bacterial pneumonia and skin infections in adults. This regulatory decision confirms…
FDA Approves Fasenra (benralizumab) for Severe Eosinophilic Asthma and EGPA
FDA approves new drug Fasenra for severe asthma and rare disease.
FDA approved Fasenra (benralizumab) for add-on maintenance treatment of severe eosinophilic asthma in patients aged 6 years and older, and f…
The FDA approved Fasenra (benralizumab) for severe asthma in patients 6 and older, and for a rare condition called EGPA in adults. It works …
FDA Approves Nuzyra (omadacycline) for Community-Acquired Bacterial Pneumonia and ABSSSI
FDA approves new antibiotic Nuzyra for pneumonia and skin infections.
The FDA approved Nuzyra (omadacycline), a tetracycline-class antibacterial, for adult patients with community-acquired bacterial pneumonia (…
The FDA approved Nuzyra (omadacycline) to treat community-acquired bacterial pneumonia and certain skin infections in adults. It is a new op…
FDA Approves Ziextenzo (pegfilgrastim-bmez) for Febrile Neutropenia and Acute Radiation Syndrome
FDA approves new biosimilar drug Ziextenzo to prevent infections in cancer patients.
The FDA approved Ziextenzo (pegfilgrastim-bmez) to decrease febrile neutropenia in patients with non-myeloid malignancies receiving myelosup…
The FDA approved Ziextenzo, a biosimilar to Neulasta, to prevent infections in cancer patients receiving chemotherapy and to treat radiation…
FDA Approves Wezlana (ustekinumab-ttwe) for Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, and Ulcerative Colitis
FDA approves Wezlana, a biosimilar to Stelara, for several inflammatory conditions.
The FDA approved Wezlana (ustekinumab-ttwe), a biosimilar to Stelara, for moderate to severe plaque psoriasis, active psoriatic arthritis, m…
The FDA approved Wezlana (ustekinumab-ttwe), a biosimilar to Stelara, for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcera…
FDA Approves Wezlana (ustekinumab-ttwe) for Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, and Ulcerative Colitis
FDA approves Wezlana, a biosimilar to Stelara, for inflammatory conditions.
The FDA approved Wezlana (ustekinumab-ttwe), a biosimilar to Stelara, for multiple indications including plaque psoriasis, psoriatic arthrit…
The FDA approved Wezlana, a biosimilar to Stelara, for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. It of…
FDA Approves Dextrose 5% Injection for Hydration and Calorie Source
FDA approves dextrose 5% injection for hydration and as drug diluent
FDA approved Dextrose 5% Injection for use as a source of calories and water for hydration in adults and pediatric patients. It is also indi…
The FDA approved Dextrose 5% Injection to provide calories and water for hydration in adults and children. It can also be used to mix with o…
FDA Approves Cardiogen-82 (Rubidium Rb 82) for Myocardial Perfusion PET
FDA approves new heart imaging drug to check blood flow in arteries.
The FDA approved Cardiogen-82, a generator producing Rubidium Chloride Rb 82 Injection, for PET myocardial perfusion imaging in adults with …
The FDA approved Cardiogen-82, a radioactive drug used with PET scans to see blood flow in the heart muscle. It helps doctors evaluate patie…
FDA Approves Abiraterone Acetate (Yonsa) for Metastatic Castration-Resistant Prostate Cancer
FDA approves new prostate cancer drug Yonsa to slow tumor growth.
The FDA approved abiraterone acetate (Yonsa) in combination with methylprednisolone for metastatic castration-resistant prostate cancer. The…
The FDA approved Yonsa (abiraterone acetate) for men with advanced prostate cancer that has spread and stopped responding to hormone therapy…
FDA Approves Inqovi (decitabine/cedazuridine) for Myelodysplastic Syndromes
FDA approves new oral drug Inqovi for certain blood cancers.
FDA approved Inqovi (decitabine 35 mg/cedazuridine 100 mg) for adults with MDS, including CMML and intermediate-1, intermediate-2, and high-…
The FDA approved Inqovi, a pill that combines two drugs, for adults with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia…
FDA approves OPDIVO QVANTIG for multiple advanced cancer indications including renal cell carcinoma and melanoma
FDA approves subcutaneous nivolumab combination for multiple advanced cancers
This FDA approval document grants authorization for OPDIVO QVANTIG, a subcutaneous combination of nivolumab and hyaluronidase, for specified…
The FDA has approved a new subcutaneous form of nivolumab for several advanced cancers, offering a more convenient treatment option for elig…
FDA Approves Tecentriq Hybreza (atezolizumab/hyaluronidase) for Multiple Cancers
FDA approves new shot form of cancer drug Tecentriq Hybreza
The FDA approved Tecentriq Hybreza, a subcutaneous formulation of atezolizumab with hyaluronidase, for multiple indications including NSCLC,…
The FDA approved Tecentriq Hybreza, a new injectable form of the cancer drug atezolizumab, for several types of cancer including lung cancer…
FDA Approves Zerbaxa (ceftolozane/tazobactam) for Complicated Infections and Pneumonia
FDA approves new antibiotic Zerbaxa for serious bacterial infections.
FDA approved Zerbaxa (ceftolozane/tazobactam) for complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI)…
The FDA approved Zerbaxa, a new antibiotic, to treat complicated abdominal and urinary tract infections, as well as hospital-acquired pneumo…
FDA Approves Tecentriq (atezolizumab) for Alveolar Soft Part Sarcoma
FDA approves first drug for rare soft tissue sarcoma in children and adults.
The FDA approved Tecentriq (atezolizumab) for adult and pediatric patients 2 years and older with unresectable or metastatic alveolar soft p…
The FDA approved Tecentriq for alveolar soft part sarcoma (ASPS), a rare cancer that often spreads. This is the first treatment specifically…
FDA approves ticagrelor for multiple indications in cardiology and neurology
Brilinta Now Approved for Stroke Prevention in Three Key Groups
The FDA approved ticagrelor (Brilinta) for patients with ACS, CAD at high risk, and acute ischemic stroke or high-risk TIA. In ACS, it was s…
A widely used heart medication now has FDA approval to prevent first strokes in people with diabetes and to protect against repeat strokes a…
FDA Approves Sodium Thiosulfate Injection for Acute Cyanide Poisoning
FDA approves new treatment for cyanide poisoning emergencies
The FDA approved Sodium Thiosulfate Injection for sequential use with sodium nitrite for treatment of acute cyanide poisoning that is seriou…
The FDA approved Sodium Thiosulfate Injection for treating serious cyanide poisoning. It is used with another drug and supportive care. This…
FDA Approves Siliq (brodalumab) for Moderate to Severe Plaque Psoriasis
FDA approves new drug Siliq for adults with plaque psoriasis
The FDA approved Siliq (brodalumab) for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or photother…
The FDA approved Siliq (brodalumab) for adults with moderate to severe plaque psoriasis who have not responded well to other treatments. Thi…
FDA Approves Sdamlo (amlodipine) for Hypertension and Coronary Artery Disease
FDA approves new blood pressure and heart drug Sdamlo for adults and children.
FDA approved Sdamlo, a calcium channel blocker, for hypertension in adults and children aged 6 years and older, and for coronary artery dise…
The FDA approved Sdamlo (amlodipine) for high blood pressure in adults and children 6 and older, and for certain types of chest pain and hea…
FDA Approves Bizengri (zenocutuzumab) for NRG1 Fusion-Positive NSCLC and Pancreatic Cancer
FDA approves new drug Bizengri for two rare lung and pancreatic cancers.
The FDA has approved Bizengri (zenocutuzumab) for adults with advanced NRG1 fusion-positive non-small cell lung cancer and pancreatic adenoc…
The FDA approved Bizengri for adults with advanced non-small cell lung cancer or pancreatic cancer that has a specific genetic change called…
FDA Approves Adempas (riociguat) for Chronic Thromboembolic and Pulmonary Arterial Hypertension
FDA approves new pill Adempas for two types of high blood pressure in lungs
The FDA approved Adempas (riociguat) for adults with persistent/recurrent CTEPH after surgery or inoperable CTEPH, and for PAH (WHO Group 1)…
The FDA approved Adempas (riociguat) for two forms of pulmonary hypertension: chronic thromboembolic pulmonary hypertension (CTEPH) and pulm…
FDA Approves Vyvgart Hytrulo (efgartigimod alfa/hyaluronidase) for CIDP and gMG
FDA approves new shot for two nerve and muscle conditions.
The FDA approved Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) for adult patients with chronic inflammatory demyelinating polyneurop…
The FDA approved Vyvgart Hytrulo, a weekly shot, for adults with generalized myasthenia gravis (gMG) or chronic inflammatory demyelinating p…
FDA Approves Vyvgart (efgartigimod alfa) for Generalized Myasthenia Gravis
FDA approves new drug Vyvgart for a form of myasthenia gravis.
The FDA approved Vyvgart (efgartigimod alfa) for generalized myasthenia gravis in adult patients who are anti-AChR antibody positive. Approv…
The FDA approved Vyvgart (efgartigimod alfa) for adults with generalized myasthenia gravis who test positive for a certain antibody. This ne…
FDA Approves Ocrevus (ocrelizumab) for Relapsing and Primary Progressive Multiple Sclerosis
FDA approves Ocrevus, a new drug for two forms of multiple sclerosis.
FDA approved Ocrevus (ocrelizumab) for relapsing forms of MS (including clinically isolated syndrome, relapsing-remitting disease, and activ…
The FDA approved Ocrevus (ocrelizumab) to treat relapsing forms of MS and primary progressive MS (PPMS) in adults. It is the first drug appr…
FDA Approves Vabrinty (leuprolide acetate) for Advanced Prostate Cancer
FDA approves new drug Vabrinty for advanced prostate cancer.
The FDA approved Vabrinty (leuprolide acetate) for the treatment of advanced prostate cancer. It is a GnRH agonist administered subcutaneous…
The FDA approved Vabrinty (leuprolide acetate) to treat advanced prostate cancer. It is a hormone therapy that lowers testosterone levels. T…
FDA Approves Talvey (talquetamab) for Relapsed/Refractory Multiple Myeloma
FDA approves new multiple myeloma drug Talvey for certain patients.
The FDA has approved Talvey (talquetamab) for adult patients with relapsed or refractory multiple myeloma who have received at least four pr…
The FDA approved Talvey (talquetamab) for adults with multiple myeloma who have tried at least four other treatments. It is for patients who…
FDA Approves Tecvayli (teclistamab) for Relapsed or Refractory Multiple Myeloma
FDA approves new drug Tecvayli for advanced multiple myeloma.
The FDA approved Tecvayli (teclistamab) for relapsed or refractory multiple myeloma in combination with daratumumab and hyaluronidase-fihj a…
The FDA approved Tecvayli (teclistamab) for adults with multiple myeloma that has come back or not responded to treatment. It is used alone …
FDA Approves Zoladex (goserelin) for Multiple Indications Including Prostate Cancer and Endometriosis
FDA approves Zoladex for prostate cancer, endometriosis, and breast cancer.
The FDA approved Zoladex (goserelin) for use in combination with flutamide for locally confined prostate cancer, palliative treatment of adv…
The FDA has approved Zoladex (goserelin) to treat prostate cancer, endometriosis, and advanced breast cancer. It is given as a shot every 28…
FDA Approves VABRINTY (leuprolide acetate) for Advanced Prostate Cancer
FDA approves Vabrinty for advanced prostate cancer with flexible dosing.
The FDA approved VABRINTY (leuprolide acetate) for the treatment of advanced prostate cancer. It is a GnRH agonist administered subcutaneous…
The FDA approved Vabrinty (leuprolide acetate) for advanced prostate cancer. It is a hormone therapy given as a shot every 1 to 6 months. Th…
FDA Approves Zoladex (goserelin) for Locally Confined and Advanced Prostate Cancer
FDA approves Zoladex for prostate cancer treatment.
FDA approved Zoladex (goserelin) for use in combination with flutamide for locally confined stage T2b-T4 prostate cancer and as palliative t…
The FDA approved Zoladex (goserelin) for two uses in prostate cancer: with radiation for early stage cancer and as palliative care for advan…
FDA Approves Levothyroxine Sodium Tablets for Hypothyroidism and TSH Suppression
FDA approves new thyroid hormone drug for hypothyroidism and thyroid cancer.
The FDA approved levothyroxine sodium tablets for replacement therapy in primary, secondary, and tertiary hypothyroidism, and as an adjunct …
The FDA has approved levothyroxine sodium tablets to treat hypothyroidism and as part of therapy for certain thyroid cancers. This synthetic…
FDA Approves Lazcluze (lazertinib) with Amivantamab for EGFR-Mutant NSCLC
FDA approves new lung cancer pill Lazcluze for certain patients.
FDA approved Lazcluze (lazertinib) in combination with amivantamab for first-line treatment of adults with locally advanced or metastatic NS…
The FDA approved Lazcluze (lazertinib) with another drug for adults with a common type of advanced lung cancer. This new oral treatment is f…
FDA Approves Perseris (risperidone) for Treatment of Schizophrenia in Adults
FDA approves new monthly shot Perseris for schizophrenia in adults.
The FDA approved Perseris, a long-acting injectable atypical antipsychotic, for the treatment of schizophrenia in adults. It is administered…
The FDA approved Perseris, a once-monthly injectable form of risperidone, for treating schizophrenia in adults. This new option may help pat…
FDA Approves Children's Advil (ibuprofen) for Fever and Minor Aches in Children
FDA approves Children's Advil for fever and pain in kids ages 2 and up.
The FDA approved Children's Advil (ibuprofen) for temporary reduction of fever and relief of minor aches and pains due to common cold, flu, …
The FDA approved Children's Advil (ibuprofen) for over-the-counter use in children as young as 2 years to reduce fever and relieve minor ach…
FDA Approves Children's Advil (ibuprofen) for Fever and Minor Aches in Children
FDA approves Children's Advil for fever and pain relief in kids.
The FDA approved Children's Advil (ibuprofen) oral suspension for temporary fever reduction and relief of minor aches and pains due to commo…
The FDA has approved Children's Advil (ibuprofen) for over-the-counter use in children to reduce fever and relieve minor aches and pains. It…
FDA Approves Precedex (dexmedetomidine) for Pediatric Procedural Sedation
FDA approves Precedex for sedation in children during procedures.
The FDA approved Precedex (dexmedetomidine) for sedation of non-intubated pediatric patients aged 1 month to less than 18 years during non-i…
The FDA approved Precedex (dexmedetomidine) to sedate children aged 1 month to 17 years during non-invasive procedures. It provides sedation…
FDA Approves Dexmedetomidine Hydrochloride for ICU and Procedural Sedation in Adults
FDA approves new sedative for hospital and procedure sedation.
FDA approved dexmedetomidine hydrochloride for sedation of initially intubated and mechanically ventilated adult patients in the ICU, and fo…
The FDA approved dexmedetomidine hydrochloride for sedation in intensive care and during procedures. It helps keep patients calm without slo…
FDA Approves Pavblu (aflibercept) for Neovascular AMD, RVO, DME, and DR
FDA approves Pavblu to treat several eye conditions that cause vision loss.
The FDA approved Pavblu (aflibercept) for neovascular AMD, macular edema following RVO, DME, and DR. It is a VEGF inhibitor administered by …
The FDA approved Pavblu (aflibercept) for wet age-related macular degeneration, macular edema, diabetic macular edema, and diabetic retinopa…
FDA Approves Ngenla (somatrogon-ghla) for Pediatric Growth Hormone Deficiency
FDA approves once-weekly growth hormone drug Ngenla for children
FDA approved Ngenla (somatrogon-ghla) for treatment of pediatric patients aged 3 years and older with growth failure due to inadequate secre…
The FDA approved Ngenla (somatrogon-ghla), a once-weekly injection for children 3 and older with growth failure due to low growth hormone. I…
FDA Approves Crestor (rosuvastatin) for Cardiovascular Risk Reduction in Adults
FDA approves Crestor to prevent heart attacks and strokes in certain adults.
FDA approved Crestor (rosuvastatin) to reduce risk of major adverse cardiovascular events in adults without established coronary heart disea…
The FDA approved Crestor (rosuvastatin) to reduce the risk of heart attack, stroke, and related events in adults without heart disease but w…
FDA Approves Hadlima (adalimumab) for Multiple Inflammatory Indications
FDA approves Hadlima, a new biosimilar for several inflammatory diseases.
The FDA approved Hadlima (adalimumab) for several inflammatory conditions including rheumatoid arthritis, juvenile idiopathic arthritis, pso…
The FDA approved Hadlima (adalimumab) for treating conditions like rheumatoid arthritis, psoriasis, and Crohn's disease. It is a biosimilar,…
FDA Approves Rexulti (brexpiprazole) for Agitation in Alzheimer's Dementia
FDA approves Rexulti to treat agitation in Alzheimer's patients
FDA approved Rexulti (brexpiprazole) for treatment of agitation associated with dementia due to Alzheimer's disease. It is not indicated for…
The FDA approved Rexulti (brexpiprazole) to treat agitation in people with Alzheimer's disease. This is a new option for managing this chall…
FDA Approves Xpovio (selinexor) for Multiple Myeloma and DLBCL
FDA approves new drug Xpovio for certain blood cancers.
The FDA approved Xpovio (selinexor) for multiple myeloma in combination with bortezomib and dexamethasone after at least one prior therapy, …
The FDA approved Xpovio (selinexor) for multiple myeloma and a type of lymphoma called DLBCL. It offers a new option for patients who have t…
FDA Approves Auvelity (dextromethorphan/bupropion) for Major Depressive Disorder and Agitation in Alzheimer's
FDA approves new drug Auvelity for depression and Alzheimer's agitation.
The FDA approved Auvelity (dextromethorphan/bupropion) for major depressive disorder (MDD) and agitation associated with dementia due to Alz…
The FDA approved Auvelity for major depressive disorder and agitation in Alzheimer's disease. It combines two medicines into one pill. This …
FDA Approves Nuplazid (pimavanserin) for Parkinson's Disease Psychosis
FDA approves first drug for hallucinations in Parkinson's disease
FDA approved Nuplazid (pimavanserin) for hallucinations and delusions associated with Parkinson's disease psychosis. In a 6-week trial, Nupl…
The FDA approved Nuplazid (pimavanserin) to treat hallucinations and delusions in people with Parkinson's disease psychosis. It is the first…
FDA Approves Enhertu (fam-trastuzumab deruxtecan-nxki) for Multiple HER2-Positive and HER2-Low Cancers
FDA approves Enhertu for several types of HER2 positive cancers.
FDA approved Enhertu for several indications including HER2-positive metastatic breast cancer, HER2-low and HER2-ultralow breast cancer, HER…
The FDA has approved Enhertu for multiple cancers, including breast, lung, stomach, and other solid tumors that have a specific protein call…
FDA Approves Nuplazid (pimavanserin) for Parkinson's Disease Psychosis
FDA approves first drug for hallucinations in Parkinson's disease
The FDA approved Nuplazid (pimavanserin) for hallucinations and delusions associated with Parkinson's disease psychosis. Approval was based …
The FDA approved Nuplazid (pimavanserin) to treat hallucinations and delusions in people with Parkinson's disease psychosis. It is the first…
FDA Approves Revlimid (lenalidomide) for Multiple Myeloma and Other Indications
FDA approves Revlimid for several blood cancers and related conditions.
FDA approved Revlimid (lenalidomide) for multiple myeloma (in combination with dexamethasone and as maintenance after auto-HSCT), transfusio…
The FDA approved Revlimid (lenalidomide) for multiple myeloma, certain myelodysplastic syndromes, mantle cell lymphoma, and other lymphomas.…
FDA Approves Breztri Aerosphere (budesonide/glycopyrrolate/formoterol) for COPD Maintenance
FDA approves new triple-combination inhaler Breztri Aerosphere for COPD.
The FDA approved Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for maintenance treatment of COPD. It is a triple-combin…
The FDA approved Breztri Aerosphere, a triple-combination inhaler, for the long-term treatment of chronic obstructive pulmonary disease (COP…
FDA Approves Pomalyst (pomalidomide) for Multiple Myeloma and Kaposi Sarcoma
FDA approves new drug Pomalyst for multiple myeloma and Kaposi sarcoma.
The FDA approved Pomalyst (pomalidomide) for multiple myeloma in combination with dexamethasone after at least two prior therapies, and for …
The FDA approved Pomalyst (pomalidomide) for two conditions: multiple myeloma and Kaposi sarcoma. It offers a new option for patients who ha…
FDA Approves Epysqli (eculizumab-sbja) for PNH, aHUS, and gMG
FDA approves new drug Epysqli for three rare blood and nerve conditions.
The FDA approved Epysqli (eculizumab-sbja) for paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and gen…
The FDA approved Epysqli (eculizumab-sbja) for paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and generalized myas…
FDA Approves Caplyta (lumateperone) for Schizophrenia in Adults
FDA approves Caplyta to treat schizophrenia in adults
FDA approved Caplyta (lumateperone) for treatment of schizophrenia in adults.
The FDA approved Caplyta (lumateperone) for treating schizophrenia in adults.
FDA Approves IC-GREEN (indocyanine green) for Fluorescence Imaging in Multiple Indications
FDA approves IC-GREEN dye to help surgeons see blood flow and tissues during operations
The FDA approved IC-GREEN (indocyanine green) for fluorescence imaging of vessels, blood flow, tissue perfusion, extrahepatic biliary ducts,…
The FDA approved IC-GREEN (indocyanine green) to help surgeons see blood vessels, bile ducts, and lymph nodes during certain surgeries.
FDA Approves Mydayis (mixed salts of a single-entity amphetamine) for ADHD in Patients 13 and Older
FDA approves new ADHD drug Mydayis for patients 13 and older
FDA approved Mydayis, a CNS stimulant, for ADHD in patients 13 years and older.
The FDA approved Mydayis, a once-daily stimulant for ADHD in people 13 and older. It can last up to 16 hours, which may cause insomnia. This…
FDA Approves Vyvanse (lisdexamfetamine) for Binge Eating Disorder in Adults
FDA approves Vyvanse to treat binge eating disorder in adults
The FDA approved Vyvanse (lisdexamfetamine) for moderate to severe binge eating disorder (BED) in adults.
The FDA has approved Vyvanse (lisdexamfetamine) for moderate to severe binge eating disorder in adults.
FDA Approves Metronidazole Injection for Anaerobic Infections and Prophylaxis
FDA approves new antibiotic for serious anaerobic bacterial infections
The FDA approved Metronidazole Injection for treatment of serious anaerobic infections and for prophylaxis in elective colorectal surgery.
The FDA approved Metronidazole Injection USP for serious infections caused by anaerobic bacteria.
FDA Approves Crysvita (burosumab) for X-Linked Hypophosphatemia and Tumor-Induced Osteomalacia
FDA approves new drug Crysvita for rare bone diseases in children and adults
FDA approved Crysvita (burosumab) for X-linked hypophosphatemia (XLH) in patients 6 months and older and for tumor-induced osteomalacia (TIO…
The FDA approved Crysvita (burosumab) for X-linked hypophosphatemia (XLH) and tumor-induced osteomalacia (TIO).
FDA Approves Vyvanse (lisdexamfetamine) for Binge Eating Disorder
FDA approves Vyvanse to treat binge eating disorder in adults
FDA approved Vyvanse (lisdexamfetamine) for moderate to severe binge eating disorder (BED) in adults.
The FDA approved Vyvanse for moderate to severe binge eating disorder in adults. It is a stimulant already used for ADHD. This gives patient…
FDA Approves Perjeta (pertuzumab) for HER2-Positive Breast Cancer
FDA approves new drug Perjeta for HER2-positive breast cancer
The FDA approved Perjeta (pertuzumab) for use in combination with trastuzumab and chemotherapy for HER2-positive metastatic breast cancer an…
The FDA approved Perjeta (pertuzumab) for HER2-positive breast cancer.
FDA Approves Zurzuvae (zuranolone) for Postpartum Depression in Adults
FDA approves new pill for postpartum depression, offering faster relief
FDA approved Zurzuvae (zuranolone) for postpartum depression (PPD) in adults.
The FDA approved Zurzuvae (zuranolone), a daily pill for postpartum depression. It works quickly over 14 days. This gives new mothers an ora…
FDA Approves Tzield (teplizumab) to Delay Onset of Stage 3 Type 1 Diabetes
FDA approves Tzield to delay type 1 diabetes in high-risk patients
The FDA approved Tzield (teplizumab) to delay the onset of Stage 3 type 1 diabetes in patients aged 1 year and older with Stage 2 disease.
The FDA approved Tzield (teplizumab) to delay the onset of stage 3 type 1 diabetes in people aged 1 and older with stage 2 disease.
FDA Approves Ontruzant (trastuzumab-dttb) for HER2-Overexpressing Breast and Gastric Cancers
FDA approves new cancer drug called Ontruzant for certain breast and stomach cancers
Ontruzant (trastuzumab-dttb) is approved for HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarc…
The FDA has approved a new drug called Ontruzant for treating certain breast and stomach cancers.
FDA Approves Cosentyx (secukinumab) for moderate to severe plaque psoriasis in adults and pediatric patients 6 years and older
The FDA has approved a new drug called Cosentyx for treating a serious skin condition
The FDA approved Cosentyx (secukinumab) for moderate to severe plaque psoriasis in adults and pediatric patients 6 years and older who are c…
The FDA approved Cosentyx for moderate to severe plaque psoriasis in adults and children 6 and older.
FDA Approves Cosentyx (secukinumab) for Moderate to Severe Hidradenitis Suppurativa in Adults and Pediatric Patients
The FDA approved a new use for the drug Cosentyx to treat a painful skin condition
The FDA has approved Cosentyx for moderate to severe hidradenitis suppurativa in adults and pediatric patients 12 years and older.
The FDA has approved Cosentyx for treating moderate to severe hidradenitis suppurativa, a chronic skin condition that causes painful lumps.
FDA Approves DATSCAN (ioflupane I-123) for Striatal Dopamine Transporter Visualization in Suspected Parkinsonian Syndromes or Dementia with Lewy Bodies
FDA approves new brain imaging drug to help doctors diagnose Parkinson's and similar conditions
DATSCAN is approved as an adjunct diagnostic for striatal dopamine transporter visualization using SPECT brain imaging in adult patients wit…
FDA approves new brain imaging drug to help doctors diagnose Parkinson's and similar conditions.
FDA Approves Stelara (ustekinumab) for moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis
The FDA approved a drug called Stelara to treat several inflammatory conditions in adults and children
The FDA approved ustekinumab for adult and pediatric patients 6 years and older with moderate to severe plaque psoriasis and active psoriati…
FDA approved Stelara to treat moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in adults an…
FDA Approves Wainua (autoinjector) for Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults
FDA approves new monthly injection called Wainua for a rare nerve disease in adults
The FDA approved Wainua, a transthyretin-directed antisense oligonucleotide, for treating polyneuropathy of hereditary transthyretin-mediate…
FDA approves new monthly injection Wainua to treat nerve damage in adults with a rare inherited disease called hereditary transthyretin-medi…
FDA Approves Stelara (ustekinumab) for moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis
The FDA has approved a new drug called Stelara for several inflammatory conditions
The FDA approved ustekinumab for adult and pediatric patients 6 years and older with moderate to severe plaque psoriasis and active psoriati…
The FDA has approved Stelara to treat moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in a…
FDA Approves Itovebi (Itovebi) for Endocrine-Resistant, PIK3CA-Mutated, HR-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
FDA approves new breast cancer drug Itovebi for a specific type of advanced cancer
The FDA approved Itovebi in combination with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, HR-positive, H…
A new oral drug, Itovebi, is now FDA-approved for advanced breast cancer with a specific genetic mutation, offering another option when horm…
FDA Approves Dupixent (dupilumab) for Allergic Fungal Rhinosinusitis in Patients with History of Sino-Nasal Surgery
FDA approves Dupixent for treating allergic fungal sinus infections in patients who have had sinus surgery
Dupixent (dupilumab) has been approved for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosi…
FDA approves Dupixent for allergic fungal sinus infections in adults and children aged 6 and older who have had sinus surgery.
FDA Approves Spravato (esketamine) for Treatment-Resistant Depression and Depressive Symptoms with Acute Suicidal Ideation in Adults
The FDA approved a new nasal spray called Spravato for severe depression
The FDA approved Spravato (esketamine) for treatment-resistant depression in adults as monotherapy or with an oral antidepressant, and for d…
FDA approved a new nasal spray for severe depression when other treatments fail or when patients face acute suicidal thoughts.
FDA Approves Abreva () for cold sores/fever blisters on the face or lips to shorten healing time and duration of symptoms
The FDA has approved a new non-prescription drug called Abreva for treating cold sores
The FDA approved Abreva for treating cold sores/fever blisters on the face or lips to shorten healing time and duration of symptoms such as …
FDA approves new over-the-counter drug Abreva to shorten cold sore healing time and ease painful symptoms like tingling and itching.
FDA Approves Rytelo (telomerase inhibitor oligonucleotide) for transfusion-dependent anemia in low- to intermediate-1 risk MDS
FDA approves new drug called Rytelo for certain blood disorder patients who need frequent transfusions
Rytelo is approved for adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) who have transfusion-dependent anemia…
FDA approves Rytelo to help adults with low-risk blood disorders who need frequent transfusions after other treatments fail.
FDA Approves Danziten (nilotinib) for Adult Patients with Newly Diagnosed or Resistant/Intolerant Ph+ CML
The FDA approved a new drug called Danziten for a type of blood cancer called CML
Danziten (nilotinib) is approved for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML)…
The FDA approved Danziten to treat newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia or cases resistant to prior ima…
FDA Approves Vanflyta (quizartinib) for Newly Diagnosed FLT3-ITD-Positive AML in Adults
FDA approves new drug called Vanflyta for a specific type of blood cancer in adults
Vanflyta is approved in combination with induction and consolidation chemotherapy, and as maintenance monotherapy, for adult patients with n…
FDA approves Vanflyta to treat acute myeloid leukemia in adults with a specific genetic change that makes the cancer harder to manage.
Prochlorperazine Labeling: Indicated for Severe Nausea/Vomiting and Schizophrenia
The FDA approved a new injection to treat severe nausea and schizophrenia when pills cannot be taken
FDA labeling for prochlorperazine lists two approved indications: control of severe nausea and vomiting and treatment of schizophrenia.
A new FDA-approved injection now treats severe nausea and schizophrenia when patients cannot take pills by mouth.
FDA Approves Concerta (methylphenidate) for ADHD in Patients Aged 6 to 65 Years
The FDA approved a new once-daily ADHD medication called Concerta for people ages 6 to 65
Concerta (methylphenidate) is approved for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years.
The FDA approved Concerta, a once-daily ADHD medication, for people ages 6 to 65 to help manage symptoms throughout the day with a single do…
FDA Approves Valproic Acid Capsules (valproic acid) for monotherapy and adjunctive therapy of complex partial seizures and absence seizures
The FDA has approved a new epilepsy drug called Valproic Acid Capsules for treating seizures
Valproic Acid Capsules were approved for monotherapy and adjunctive therapy of complex partial seizures, and sole and adjunctive therapy of …
The FDA approved Valproic Acid Capsules to treat complex partial and absence seizures in people aged 10 and older.
FDA Approves Rezenopy (naloxone) for Emergency Treatment of Opioid Overdose
FDA approves new nasal spray called Rezenopy for emergency treatment of opioid overdose
The FDA approved Rezenopy nasal spray for emergency treatment of known or suspected opioid overdose in adult and pediatric patients.
FDA approves new nasal spray Rezenopy to quickly reverse opioid overdose in adults and children when someone shows slow breathing or is unre…
FDA Approves Cosopt Pf (dorzolamide hydrochloride-timolol maleate ophthalmic solution) for reduction of elevated intraocular pressure in open-angle glaucoma or ocular hypertension
The FDA approved a new preservative-free eye drop called Cosopt Pf for treating high eye pressure
FDA approved Cosopt Pf, a preservative-free ophthalmic solution of dorzolamide hydrochloride and timolol maleate, for reducing elevated intr…
FDA approves new preservative-free eye drop for high eye pressure in patients who don't respond well to beta-blockers.
FDA Approves Onureg (azacitidine) for Continued Treatment of Adult AML Patients in First Remission After Intensive Chemotherapy
The FDA approved a new oral drug called Onureg for certain leukemia patients in remission
FDA approved Onureg for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission or complete …
FDA approved oral drug Onureg for leukemia patients in remission who cannot complete intensive curative therapy.
FDA Approves Lamotrigine Tablets (lamotrigine) for Epilepsy and Bipolar Disorder Maintenance
The FDA has approved a drug called lamotrigine for epilepsy and bipolar disorder treatment
Lamotrigine tablets were approved as adjunctive therapy for partial-onset seizures, PGTC seizures, and Lennox-Gastaut syndrome in patients a…
The FDA has approved lamotrigine to help control seizures in children as young as two and maintain mood stability for adults with bipolar di…
FDA Approves Vabysmo (faricimab) for Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema, and Macular Edema Following Retinal Vein Occlusion
The FDA approved a new eye medicine called Vabysmo for several vision conditions
Vabysmo (faricimab) is approved for neovascular age-related macular degeneration, diabetic macular edema, and macular edema following retina…
FDA approved Vabysmo to treat wet age-related macular degeneration, diabetic macular edema, and swelling after retinal vein occlusion.
FDA Approves Fosfomycin Tromethamine (fosfomycin tromethamine) for Uncomplicated Urinary Tract Infections in Women
FDA approves new single-dose antibiotic for treating bladder infections in women
Fosfomycin tromethamine granules for oral solution was approved for uncomplicated urinary tract infections (acute cystitis) in women due to …
FDA approves a new single-dose antibiotic for women with bladder infections, offering a convenient one-time treatment option for common urin…
FDA Approves Beyfortus (nirsevimab-alip) for Prevention of RSV Lower Respiratory Tract Disease in Neonates and Infants
FDA approves new drug called Beyfortus to help protect babies and young children from serious RSV illness
Beyfortus is approved for preventing RSV lower respiratory tract disease in neonates and infants during their first RSV season, and in child…
FDA approves Beyfortus to prevent serious RSV illness in newborns and infants during their first season and children up to 2 years old in th…
FDA Approves Skyclarys for Friedreich's Ataxia in Adults and Adolescents Aged 16 Years and Older
The FDA has approved a new drug called Skyclarys for a rare nerve disorder
Skyclarys is approved for treating Friedreich's ataxia in adults and adolescents aged 16 years and older.
The FDA has approved Skyclarys to treat Friedreich's ataxia, a rare nerve disorder that causes movement problems in adults and teens aged 16…
FDA Approves Ondansetron Injection, USP (ondansetron hydrochloride) for prevention of nausea and vomiting associated with emetogenic cancer chemotherapy and postoperative nausea/vomiting
FDA approves a new injection to help prevent nausea and vomiting from cancer treatment and surgery
FDA approved ondansetron injection for prevention of nausea and vomiting associated with emetogenic cancer chemotherapy and postoperative na…
FDA approves new injection to prevent nausea and vomiting from cancer treatment and surgery for children as young as one month old.
FDA Approves Tyvaso (treprostinil) for Pulmonary Arterial Hypertension and Pulmonary Hypertension Associated with Interstitial Lung Disease
FDA approves new inhaled drug called Tyvaso for two serious lung conditions
The FDA approved Tyvaso (treprostinil) for pulmonary arterial hypertension (PAH; WHO Group 1) and pulmonary hypertension associated with int…
FDA approves new inhaled drug Tyvaso to help adults with serious lung conditions improve their ability to exercise and do daily activities.
FDA Approves Dapagliflozin Tablets (dapagliflozin) for Heart Failure Risk Reduction and Glycemic Control in Type 2 Diabetes
FDA approves a diabetes drug that also helps protect the heart in certain adults
The FDA has approved dapagliflozin tablets to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and establ…
A new diabetes tablet now helps control blood sugar while also lowering the risk of heart failure hospitalization for adults with heart dise…
FDA Approves Dapagliflozin Tablets (dapagliflozin) for Type 2 Diabetes and Heart Failure Risk Reduction
FDA approves a new pill for type 2 diabetes that also helps protect the heart
The FDA has approved dapagliflozin tablets for two indications in adults with type 2 diabetes mellitus: to improve glycemic control and to r…
A new FDA-approved pill for type 2 diabetes now helps lower blood sugar while also reducing the risk of hospitalization for heart failure.
FDA Approves Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets for Type 2 Diabetes and Related Risks
FDA approves a new once-daily pill for type 2 diabetes that may also help protect the heart and kidneys
The FDA has approved dapagliflozin and metformin hydrochloride extended-release tablets as an adjunct to diet and exercise to improve glycem…
A new once-daily pill for type 2 diabetes may protect the heart and kidneys from serious problems like heart attacks and worsening kidney di…
FDA Approves Cefepime for Injection and Dextrose Injection (cefepime) for Moderate to Severe Pneumonia and Other Infections
The FDA approved a new ready-to-use version of an antibiotic called cefepime for serious infections
The FDA approved cefepime in a dextrose injection formulation for intravenous treatment of moderate to severe pneumonia, febrile neutropenia…
The FDA approved a ready-to-use antibiotic for serious infections like pneumonia and urinary tract infections in hospitalized patients.
FDA Approves Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for PSMA-positive metastatic castration-resistant prostate cancer
FDA approves a new treatment for advanced prostate cancer called Pluvicto
The FDA has approved Pluvicto, a radioligand therapeutic agent, for the treatment of adult patients with PSMA-positive metastatic castration…
FDA approves Pluvicto, a targeted radiation therapy for advanced prostate cancer that has spread and stopped responding to standard hormone …
FDA Approves Levetiracetam for Partial-Onset, Myoclonic, and Primary Generalized Tonic-Clonic Seizures
FDA approves a seizure medicine called levetiracetam for children and adults
Levetiracetam is approved for the treatment of partial-onset seizures in patients 1 month and older, and as adjunctive therapy for myoclonic…
The FDA now approves levetiracetam for children as young as one month and adults to treat specific seizure types.
FDA Approves Ingrezza Sprinkle (valbenazine) for Tardive Dyskinesia and Chorea Associated with Huntington’s Disease
FDA approves a new sprinkle version of Ingrezza for two movement disorders
The FDA has approved Ingrezza Sprinkle, a VMAT2 inhibitor, for the treatment of adults with tardive dyskinesia and chorea associated with Hu…
FDA approves sprinkle form of Ingrezza to treat involuntary movements in adults with tardive dyskinesia or Huntington's disease chorea.
FDA Approves Ondansetron Injection, USP (ondansetron hydrochloride) for Prevention of Chemotherapy-Induced and Postoperative Nausea/Vomiting
FDA approves a new preservative-free injection to prevent nausea and vomiting from chemotherapy and surgery
FDA approved ondansetron injection for prevention of nausea/vomiting associated with emetogenic cancer chemotherapy and postoperative nausea…
FDA approves a new preservative-free injection to prevent nausea and vomiting from chemotherapy and surgery.
FDA Approves Gabapentin Capsules (gabapentin) for Postherpetic Neuralgia and Partial Onset Seizures
FDA approves a new generic version of the drug gabapentin for nerve pain and seizures
The FDA has approved Gabapentin Capsules, USP for the management of postherpetic neuralgia in adults and as adjunctive therapy for partial o…
FDA approves a new generic gabapentin capsule for nerve pain and seizures, offering patients another low-cost treatment option alongside exi…
FDA Approves Dapagliflozin Tablets (dapagliflozin) to Reduce Heart Failure Hospitalization Risk and Improve Glycemic Control in Adults with Type 2 Diabetes
FDA approves a diabetes drug that also helps protect the heart in certain adults
The FDA has approved dapagliflozin tablets to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus a…
A new diabetes drug is approved to lower blood sugar and cut the risk of heart failure hospitalization in adults with type 2 diabetes and he…
FDA Approves Dapagliflozin for Heart Failure Risk Reduction and Glycemic Control in Type 2 Diabetes
FDA approves a diabetes drug that also helps protect the heart from failure
The FDA has approved dapagliflozin to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and established ca…
FDA approves a diabetes pill that lowers blood sugar and reduces heart failure hospitalization for adults with type 2 diabetes and heart ris…
FDA Approves Dapagliflozin for Reducing Heart Failure Hospitalization Risk and Improving Glycemic Control in Adults with Type 2 Diabetes
FDA approves a diabetes drug that also helps protect the heart
The FDA has approved dapagliflozin to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and estab…
A new diabetes drug now helps lower blood sugar while also reducing the risk of heart failure hospitalization for adults with heart disease …
FDA Approves Dapagliflozin Tablets (dapagliflozin) for Type 2 Diabetes and Heart Failure Risk Reduction
FDA approves a new diabetes pill that also helps protect the heart
The FDA has approved dapagliflozin tablets for two indications: to improve glycemic control in adults with type 2 diabetes mellitus, and to …
A new daily diabetes pill now approved by the FDA helps lower blood sugar and reduces the risk of heart failure hospitalization for adults w…
FDA Approves Dapagliflozin Tablets (dapagliflozin) for Heart Failure Risk Reduction and Glycemic Control in Type 2 Diabetes
FDA approves a diabetes pill that also helps protect the heart from failure
The FDA has approved dapagliflozin tablets to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and establ…
A new diabetes pill approved by the FDA also lowers the risk of hospitalization for heart failure in adults with type 2 diabetes.
FDA Approves Dapagliflozin Tablets (dapagliflozin) for Heart Failure Risk Reduction and Glycemic Control in Type 2 Diabetes
FDA approves a diabetes drug that also helps lower the risk of heart failure
The FDA has approved dapagliflozin tablets to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and establ…
A new diabetes pill now helps lower blood sugar and reduces the risk of hospitalization for heart failure in adults with type 2 diabetes.
FDA Approves Keytruda (pembrolizumab) for Treatment of Unresectable or Metastatic Melanoma
FDA approves new drug Keytruda for advanced skin cancer
The FDA has approved Keytruda, a PD-1-blocking antibody, for the treatment of patients with unresectable or metastatic melanoma.
FDA approves Keytruda to treat advanced skin cancer that cannot be removed by surgery or has spread to other parts of the body.
FDA Approves Dapagliflozin Tablets (dapagliflozin) to Reduce Heart Failure Hospitalization Risk in Adults with Type 2 Diabetes
FDA approves a diabetes drug that also helps protect the heart
The FDA has approved dapagliflozin tablets to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus a…
A new diabetes drug now protects the heart by lowering hospitalization risks for adults with type 2 diabetes and existing heart disease.
FDA Approves Valproic Acid Oral Solution (valproic acid) for Monotherapy and Adjunctive Therapy of Complex Partial and Absence Seizures
The FDA has approved a liquid form of an existing epilepsy and migraine prevention medicine
The FDA has approved valproic acid oral solution for monotherapy and adjunctive therapy of complex partial seizures, and as sole and adjunct…
The FDA approved a liquid version of valproic acid, an established epilepsy and migraine medicine, offering an easier swallowing option for …
FDA Approves Valproic Acid Oral Solution (valproic acid) for Monotherapy and Adjunctive Therapy of Complex Partial and Absence Seizures
FDA approves a liquid form of an existing epilepsy medicine called valproic acid
The FDA has approved valproic acid oral solution for monotherapy and adjunctive therapy of complex partial seizures, and as sole and adjunct…
FDA approves liquid valproic acid for epilepsy patients 10 and older who struggle to swallow pills or need flexible dosing.
FDA Approves Valproic Acid Oral Solution (valproic acid) for Complex Partial and Absence Seizures
The FDA has approved a liquid form of an older seizure medicine called valproic acid
Valproic acid oral solution is approved as monotherapy and adjunctive therapy for complex partial seizures and for simple and complex absenc…
The FDA approved a liquid version of valproic acid to help adults and children over 10 manage complex partial and absence seizures when pill…
FDA Approves Eylea HD (aflibercept) for nAMD, DME, Diabetic Retinopathy, and Macular Edema Following RVO
FDA approves a new, higher-dose version of the eye medicine Eylea
The FDA has approved Eylea HD, a VEGF inhibitor, for the treatment of neovascular age-related macular degeneration, diabetic macular edema, …
FDA approves higher-dose Eylea to treat four eye conditions that damage the retina and threaten vision, potentially reducing how often patie…
FDA Approves Nintedanib Capsules (nintedanib esylate) for Idiopathic Pulmonary Fibrosis and Progressive Fibrosing ILDs
FDA approves a new drug to treat two types of progressive, scarring lung diseases
The FDA has approved nintedanib capsules for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and for adults with chronic fi…
FDA approves new drug to treat two types of progressive, scarring lung diseases that make lungs stiff and hard to breathe.
FDA Approves Nintedanib Capsules (nintedanib esylate) for Idiopathic Pulmonary Fibrosis and Progressive Fibrosing ILDs
FDA approves a new drug to treat two serious, scarring lung diseases in adults
The FDA has approved nintedanib capsules for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and for adults with chronic fi…
FDA approves new drug nintedanib to treat two serious, scarring lung diseases in adults with progressive conditions.
FDA Approves FOUNDAYO (orforglipron) for chronic weight management in adults with obesity or overweight with comorbidities
The FDA has approved a new daily pill called FOUNDAYO to help adults manage their weight
The FDA has approved FOUNDAYO (orforglipron), an oral GLP-1 receptor agonist, for chronic weight management in adults with obesity or overwe…
FDA approves new daily pill FOUNDAYO for adults to manage weight alongside diet and exercise.
FDA Approves Kesimpta (ofatumumab) for Relapsing Forms of Multiple Sclerosis in Adults
The FDA approved a new monthly self-injection drug for multiple sclerosis
The FDA has approved Kesimpta, a CD20-directed cytolytic antibody, for the treatment of relapsing forms of multiple sclerosis in adults.
The FDA approved Kesimpta, a new monthly self-injection for adults with relapsing forms of multiple sclerosis.
FDA Approves Vafseo (vadadustat) for Anemia Due to Chronic Kidney Disease in Adults on Dialysis
FDA approves a new oral pill for anemia in adults with chronic kidney disease on dialysis
The FDA has approved Vafseo (vadadustat) for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysi…
FDA approves a new oral pill for anemia in adults with chronic kidney disease on dialysis, offering a non-transfusion option for those treat…
FDA Approves Zynyz (retifanlimab-dlwr) for Metastatic Anal Canal Cancer and Merkel Cell Carcinoma
FDA approves new drug Zynyz for two rare and aggressive types of cancer
The FDA has approved Zynyz, a PD-1 blocking antibody, for two indications: first-line treatment of inoperable locally recurrent or metastati…
FDA approves new drug Zynyz to treat two rare and aggressive cancers: advanced anal cancer and Merkel cell carcinoma.
FDA Approves Lamotrigine for Adjunctive Therapy in Epilepsy and Maintenance in Bipolar I Disorder
FDA approves lamotrigine, a medicine for epilepsy and bipolar disorder
Lamotrigine is approved for adjunctive therapy of partial-onset seizures, PGTC seizures, and seizures of Lennox-Gastaut syndrome in patients…
The FDA officially approves lamotrigine for epilepsy and bipolar disorder, confirming a long-used treatment option for adults and children a…
FDA Approves Bupropion Hydrochloride Extended-Release Tablets (SR) (bupropion) for Major Depressive Disorder
FDA approves a new, longer-acting version of the antidepressant bupropion
The FDA has approved Bupropion Hydrochloride Extended-Release Tablets (SR) for the treatment of major depressive disorder (MDD).
A new extended-release antidepressant now helps adults manage depression for up to 44 weeks following initial treatment.
FDA Approves Byooviz (ranibizumab) for Neovascular AMD, Macular Edema Following RVO, and Myopic CNV
FDA approves a new eye medicine called Byooviz for three conditions that can cause vision loss
The FDA has approved Byooviz, a VEGF inhibitor, for intravitreal injection to treat neovascular age-related macular degeneration, macular ed…
FDA approves Byooviz to treat three eye conditions causing vision loss from leaky blood vessels in the retina.
FDA Approves Focinvez (fosaprepitant) for Prevention of Chemotherapy-Induced Nausea and Vomiting
FDA approves a new intravenous drug to help prevent nausea and vomiting from chemotherapy
The FDA has approved Focinvez, a substance P/NK1 receptor antagonist, for the prevention of acute and delayed nausea and vomiting associated…
FDA approves new IV drug to prevent severe nausea and vomiting from chemotherapy in adults and children 6 months and older.
FDA Approves Depakote Sprinkle Capsules (valproate) for Monotherapy and Adjunctive Therapy of Complex Partial and Absence Seizures
FDA approves a new sprinkle capsule form of the epilepsy drug Depakote
The FDA approved Depakote Sprinkle Capsules (valproate) for monotherapy and adjunctive therapy of complex partial seizures and simple and co…
FDA approves a sprinkle capsule form of Depakote that patients can open and mix with soft food to help those who struggle to swallow pills.
FDA Approves Depakote ER (divalproex sodium) for Acute Manic or Mixed Episodes in Bipolar Disorder
FDA approves a new once-daily pill for treating manic episodes in bipolar disorder
The FDA has approved Depakote ER, an extended-release valproate, for the acute treatment of manic or mixed episodes associated with bipolar …
FDA approves a new once-daily pill for short-term treatment of severe manic episodes in adults with bipolar I disorder.
FDA Approves Valproate Sodium Injection (valproate sodium) for IV Use in Complex Partial and Absence Seizures
FDA approves an injectable version of an existing seizure medicine for short-term use
The FDA approved Valproate Sodium Injection as an intravenous alternative when oral valproate is temporarily not feasible.
FDA approves an injectable seizure medicine for short-term use when patients can't swallow pills due to surgery or stomach issues.
FDA Approves Depakote (divalproex sodium) for Manic Episodes Associated with Bipolar Disorder
FDA approves Depakote for treating manic episodes in bipolar disorder
The FDA approved Depakote (divalproex sodium) for the treatment of manic episodes associated with bipolar disorder.
FDA approves Depakote for treating manic episodes in hospitalized adults with bipolar disorder, offering doctors a new option for managing a…
FDA Approves Xarelto (rivaroxaban) for multiple indications including stroke prevention in nonvalvular atrial fibrillation and treatment of VTE
FDA approves a new blood thinner called Xarelto for several heart and clot conditions
The FDA approved rivaroxaban (Xarelto), a factor Xa inhibitor, for multiple indications including reducing stroke risk in nonvalvular atrial…
FDA approves new blood thinner Xarelto to prevent dangerous clots in heart conditions, deep vein issues, and after major surgeries.
FDA Approves Children's Zyrtec Allergy (cetirizine) for Symptoms of Upper Respiratory Allergies
FDA approves a chewable allergy medicine for children called Children's Zyrtec Allergy
The FDA approved Children's Zyrtec Allergy (cetirizine) for temporarily relieving symptoms of hay fever or other upper respiratory allergies…
FDA approves chewable allergy medicine for kids as young as 2 to help with runny nose, sneezing, and itchy eyes from hay fever.
FDA Approves Ringer's In Plastic Container (Ringer's solution) for parenteral replacement of extracellular fluid and electrolyte losses
The FDA approved a new intravenous fluid called Ringer's In Plastic Container
The FDA approved Ringer's In Plastic Container for parenteral replacement of extracellular losses of fluid and electrolytes, as required by …
FDA approves new IV fluid to replace lost water and minerals like sodium and potassium for patients needing hydration after surgery or from …
FDA Approves Xarelto (rivaroxaban) for Thromboprophylaxis in Pediatric Patients After Fontan Procedure
FDA approves Xarelto to help prevent blood clots in children with certain heart conditions
The FDA approved rivaroxaban (Xarelto) for thromboprophylaxis in pediatric patients aged 2 years and older with congenital heart disease who…
FDA approves Xarelto to prevent dangerous blood clots in children aged 2 and older born with heart defects who have had Fontan surgery.
FDA Approves Marinol (dronabinol) for AIDS-Related Anorexia and Chemotherapy-Induced Nausea/Vomiting
FDA approves a new drug called Marinol to help with AIDS-related weight loss and chemotherapy nausea
The FDA has approved Marinol (dronabinol) for two indications in adults: anorexia associated with weight loss in patients with AIDS, and nau…
The FDA approved Marinol to treat AIDS-related weight loss and severe chemotherapy nausea that standard treatments couldn't control.
FDA Approves Winrevair for Pulmonary Arterial Hypertension (PAH) in Adults
FDA approves a new treatment for a serious lung condition called pulmonary arterial hypertension
The FDA has approved Winrevair for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to improve exercise capac…
A new FDA-approved injection helps adults with pulmonary arterial hypertension exercise longer, improve daily life, and lower the risk of ho…
FDA Approves Elrexfio for Relapsed or Refractory Multiple Myeloma After Four Prior Lines of Therapy
The FDA approved a new treatment for a type of blood cancer called multiple myeloma
The FDA has approved Elrexfio, a bispecific BCMA-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myelom…
A new FDA-approved treatment helps shrink multiple myeloma in patients who have already tried at least four other therapies.
FDA Approves Methylphenidate Hydrochloride Extended-Release Tablets for ADHD and Narcolepsy
The FDA has approved a new, longer-acting generic version of a common ADHD and narcolepsy medication
The FDA has approved methylphenidate hydrochloride extended-release tablets for the treatment of Attention Deficit Hyperactivity Disorder (A…
The FDA approved a new generic ADHD and narcolepsy medicine that works for about 8 hours, offering a longer-lasting option for patients 6 ye…
FDA Approves Krazati (adagrasib) for KRAS G12C-Mutated NSCLC and in Combination for Colorectal Cancer
FDA approves a new targeted cancer drug called Krazati for lung and colorectal cancers
The FDA has approved Krazati as a single agent for adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC after at least…
FDA approves Krazati, a new targeted drug for lung and colorectal cancers with a specific genetic change after other treatments fail.